UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056373 |
|---|---|
| Receipt number | R000063000 |
| Scientific Title | Efficacy of the Hybrid Return to Work (HR2W) Program for Workers on Leave: A Feasibility Study |
| Date of disclosure of the study information | 2024/12/05 |
| Last modified on | 2025/12/10 19:51:02 |
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Basic information
Public title
Efficacy of the Hybrid Return to Work (HR2W) Program for Workers on Leave: A Feasibility Study
Acronym
HR2W
Scientific Title
Efficacy of the Hybrid Return to Work (HR2W) Program for Workers on Leave: A Feasibility Study
Scientific Title:Acronym
HR2W
Region
| Japan |
Condition
Condition
Mental health-related leaves of absence
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the feasibility of a hybrid rework program (HR2W) in a clinical setting. This program combines a brief, facility-based group rework component with a self-guided learning program delivered through a smartphone application designed for individuals on mental health-related leaves of absence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The primary outcome measure will be perceived difficulty in returning to work using a Difficulties in Returning to Work Inventory (Tanoue et al., 2012). Assessments will be measured at three time points: pre-intervention (Time 1), post-intervention (Time 1 + 2 months), and 6 months post-intervention (Time 1 + 8 months).
Key secondary outcomes
Quantitative Evaluation:
Psychiatric Rework Readiness Scale (PRRS)
Quick Inventory of Depressive Symptomatology (QIDS-J)
Athens Insomnia Scale (AIS)
EuroQol 5 Dimensions (EQ-5D)
Tri-Axial Coping Scale (TAC-24)
Program Satisfaction
Frequency and Continuity of App Usage
Program Participation Rate and Continuation Rate
Return to Work Rate
Qualitative Evaluation
A semi-structured interview of approximately 30 minutes will be conducted based on an interview guide at the post-intervention assessment (Time 2). The interview will include questions regarding participants' experience with the HR2W, feedback on its contents, and expectations for the program.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
The group program and the mental health app (Awarefy) consist of seven components: psychological education on the return-to-work process, health, daily rhythm, work stamina recovery, communication, mental preparation for return to work, and acquisition of psychological skills.
The group program sessions are facilitated by either facility staff or a researcher who is a licensed psychologist. The program is structured into 16 sessions, intended to be completed within approximately two months. Participants attend two group sessions per week at the rework facility, with each session lasting up to about 60 minutes. At the end of each session, participants complete a feedback survey, which includes reflection on the content and session satisfaction.
In addition to the group program, participants are provided free access to a mental health app, Awarefy, which includes psychological content such as rework program exercises and activities conducted in the group sessions. The app' s content is developed by certified clinical psychologists or licensed psychologists based on the principles of Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT). Using this app, participants can review the rework program content outside the rework facility. Instructions on how to use the app are provided during the in-person group sessions. While daily app usage is not mandatory, participants who miss group sessions or wish to review content are encouraged to use the app according to their needs.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Persons on leave due to mental illness
- Persons who are 18 years of age or older
- Persons who have agreed to participate in this study
Key exclusion criteria
- Individuals diagnosed with bipolar and related disorders (including manic episodes), intellectual disabilities, eating disorders, PTSD, alcohol or substance dependence, obsessive-compulsive disorder, schizophrenia, severe developmental disorders, or other conditions where the risks of this intervention program are deemed to outweigh its benefits.
- Individuals with strong suicidal ideation.
- Individuals with severe physical comorbidities.
- Individuals for whom the primary physician, study investigators, or facility staff at the research institution judge that the risks of participation to the program outweigh its benefits.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Eguchi |
Organization
University of Occupational and Environmental Health, Japan
Division name
Institute of Industrial Ecological Sciences
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka
TEL
093-603-1611
j-seihkn@mbox.med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Hikari |
| Middle name | N. |
| Last name | Takashina |
Organization
Awarefy Inc.
Division name
NA
Zip code
163-0548
Address
Shinjuku Nomura Building 48-4808, 1-26-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-6824-1730
Homepage URL
hikari.takashina@awarefy.com
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Awarefy Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Medical Research, University of Occupational and Environmental Health, Japan
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka
Tel
093-691-7205
daigakurinri@mbox.pub.uoeh-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063000
